Bulk Manufacturer of Controlled Substances Application: Noramco Inc.

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Federal RegisterNov 5, 2019
84 Fed. Reg. 59645 (Nov. 5, 2019)

ACTION:

Notice of application.

DATES:

Registered bulk manufacturer of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 6, 2020.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(a), this is notice that on August 6, 2019, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Codeine-N-oxide 9053 I
Dihydromorphine 9145 I
Hydromorphinol 9301 I
Morphine-N-oxide 9307 I
Amphetamine 1100 II
Methylphenidate 1724 II
Nabilone 7379 II
Phenylacetone 8501 II
Codeine 9050 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Hydromorphone 9150 II
Hydrocodone 9193 II
Morphine 9300 II
Oripavine 9330 II
Thebaine 9333 II
Opium extracts 9610 II
Opium fluid extract 9620 II
Opium tincture 9630 II
Opium, powdered 9639 II
Opium, granulated 9640 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Tapentadol 9780 II

The company plans to manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for supply to its customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.

Dated: October 22, 2019.

William T. McDermott,

Assistant Administrator.

[FR Doc. 2019-24106 Filed 11-4-19; 8:45 am]

BILLING CODE 4410-09-P